GSK announces start of a phase II study to evaluate an anti GM-CSF antibody for inflammatory hand osteoarthritis

Issued: London

GSK today announced the start of a phase II study to evaluate the efficacy and safety of GSK3196165, an investigational anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody, in patients with inflammatory hand osteoarthritis.

Osteoarthritis is a condition that causes damage to the surface of joints in the body leading to joint pain and stiffness. In some patients it can adversely affect work and normal daily activities.

The primary objective of the randomised, multicentre, double-blind, placebo-controlled parallel group study is to assess the efficacy potential of subcutaneous injections of GSK3196165 on pain. Secondary objectives include the assessment of safety and pharmacokinetics of GSK3196165.

GSK3196165 is one of the ~40 assets profiled to investors at GSK’s R&D event in November 2015 and belongs to the company’s immuno-inflammation portfolio – one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.

The asset is also in phase II development as a potential treatment for rheumatoid arthritis. It is not approved for use anywhere in the world.

Paul-Peter Tak, Chief Immunology Officer & Senior Vice President R&D Pipeline said: “We are pleased to be progressing GSK3196165 - an anti GM-CSF antibody - which is part of our broad portfolio of innovative immuno-modulating medicines in clinic development, for another indication. The start of this study is our first step to help patients with osteoarthritis – a painful disease that can affect any joint in the body. We have begun our clinical plans by investigating the potential of GSK3196165 in a particular group of patients with hand osteoarthritis. We hope this study will provide informative results to shape our future plans for osteoarthritis”.

About GSK3196165

GSK3196165 is a monoclonal antibody which blocks the effects of granulocyte-macrophage colony-stimulating factor (GM-CSF), a pro-inflammatory cytokine (a chemical messenger) that plays a key role in a broad range of inflammatory diseases including osteoarthritis and rheumatoid arthritis. It activates cells, including macrophages (a white blood cell which plays a key role in the inflammatory process), leading to inflammation and joint damage.

In 2013 GSK assumed exclusive worldwide responsibility of GSK3196165 (previously MOR103) from MorphoSys AG for all development and commercialisation activities in all therapeutic fields.

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